A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair

Vaginal Atrophy Clinical Trial

Official title:

A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair: A Non-randomized, Open, Inter-group and Self-controlled Trial Before and After Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492176
• Other study ID #: XijingH-PF-20190718
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. Laser therapy with small trauma and short repair time has attracted much attention.

2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.

3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells.

Description:

1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. It should be noted that patients with vaginal constriction need anti-scar training for a long time after operation to prevent the effect of vaginal entrance narrowing and vaginal wall scar formation on the quality of life of patients during the repair period. Therefore, laser therapy with small trauma and short repair time has attracted much attention.

2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal Internal environment and bacterial flora, and then reduce the probability of gynecological infection.

3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells. Our center has also passed the clinical observation ethical review of CO2 lattice laser to improve female vaginal relaxation in 2016, and completed the clinical trial at the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal relaxation and is significantly effective for stress urinary incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Married women aged 25-75 with improvement needs;

• Agree to participate in the experiment and sign the informed consent.

• Female sexual dysfunction patients;

• No other external treatment was performed before treatment at the lesion site.

• VTI instrument was used for intravaginal pressure test to assess urinary incontinence and vaginal senility caused by chronic muscle dysfunction

Exclusion Criteria:

• Pregnant or lactating women;

• suffering from severe mental disorders, psychological disorders, personality disorders and major organ dysfunction;

• Patients with severe hematological diseases, Sjogren's syndrome, systemic and therapeutic site infections;

• Patients who took high doses of anticoagulants or hormones within one month;

• Laser allergy history, photosensitive reactor;

• Women with acute vaginitis or cervicitis;

• Pap smear positive patients;

• Female HIV (HIV), HPV (papillary virus), HSV (herpes simplex virus) positive patients;

• Use of antifungal drugs, vaginal administration, vaginal irrigation and female sprays in the past 30 days

• The condition of the visual field of laser surgery affected by ulceration and infection of the skin lesion

• Those who have undergone vaginal tightening surgery with other substances or means

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Device:
• CO2 fractional laser(ACUPULSE,Lumenis)
gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times

Locations

Country	Name	City	State
China	Dermatology Derpartment of Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	female sexual function FSFI score(Female Sexual Function Index )	Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score = 26.55 is considered female sexual dysfunction	Changes from preoperative to 1 year after initial treatment
Primary	urinary incontinence questionnaire short form assessment	Evaluate urinary incontinence questionnaire short form assessment	Changes from preoperative to 1 year after initial treatment
Primary	VHIS score in vaginal environment	Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness	Changes from preoperative to 1 year after initial treatment
Primary	vaginal pressure VTI data detection	Evaluate vaginal pressure by VTI data detection	Changes from preoperative to 1 year after initial treatment
Primary	pelvic floor magnetic resonance MRI plain	Measure tissue structures in the pelvis	Changes from preoperative to 1 year after initial treatment
Primary	scantransvaginal ultrasound	Measure the structures of the vagina	Changes from preoperative to 1 year after initial treatment
Primary	histopathological biopsy	5 cases were randomly selected for histopathological biopsy	Changes before and 1month after treatment
Secondary	patient satisfaction assessment	Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied	Changes from preoperative to 1 year after initial treatment
Secondary	VAS Pain Assessment(Immediately after Treatment)	VAS pain scoring criteria (0-10 points): 0 points: no pain; less than 3 points: mild pain, can tolerate; 4 points 1-6 points: patients with pain and affect sleep, can still tolerate; 7 points-10 points : The patient has increasing pain, and the pain is intolerable	3 months